New Drug Development and Review Process

The mission of FDA's Center for Drug Evaluation and Research is to assure that safe and effective drugs are available to the American people. The information below provides an understanding of how CDER works to accomplish this mission as it relates to new drug development and review.

	New Drug Development Process- An interactive chart that provides an overview of the new drug development process, with an emphasis on preclinical research and clinical studies conducted by the drug's sponsor.
	Investigational New Drug (IND) Review Process- An interactive chart that provides an overview of CDER's investigational new drug application process, including how CDER determines if the product is suitable for use in clinical trials.
	New Drug Application (NDA) Review Process- An interactive chart that provides an overview of CDER's new drug application review process, including how CDER determines the benefit:risk profile of a drug product prior to approval for marketing.